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MEDIVATORS INC.

United States·US-MF-000043422

Last updated September 17, 2026

Information

Country: United States
Address: 3150, Pollok Dr, Conroe, United States
Website: www.steris.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)444-4729
PRRC Contact: Zeeshan Shamim
EUDAMED SRN: US-MF-000043422
FDA FEI Number: 3003012447
DUNS Number: 068199363

Catalogue (5153)

Page 77 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPK-103015-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002343	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006230	FDA UDI	Class II	Active
Custom Procedure Kit	4000600	FDA UDI	Class II	Active
Essential Kit	4000940	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-106778-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100684-0004	FDA UDI	Class II	Active
Custom Procedure Kit	4000284	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-530800-0001	FDA UDI	Class I	Unknown
Cleanascope/Defendo-Bund	580315	FDA UDI	Class I	Active
FiberFlo	93023-146	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-200108-0002	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009853	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4001555	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-106663-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008315	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009228	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008145	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103407-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101839	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109559-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001473	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107807-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004563	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-916660-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-782404-0001	FDA UDI	Class I	Unknown
Endo Smartcap	100145CO2EXT	FDA UDI	Class II	Active
Custom Procedure Kit	4005617	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-736500-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105831-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-822925-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003312	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-105701-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-108042-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-104356-0003	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-109533-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200843-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009443	FDA UDI	Class II	Active
Custom Procedure Kit	4000025	FDA UDI	Class II	Active
Custom Procedure Kit	4000681	FDA UDI	Class II	Active
Backflow Valve Connector	100126P	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-104344-0006	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010429	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101215-0010	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200750-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000273	FDA UDI	Class II	Active
Custom Procedure Kit	4001950	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009811	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

STERIS Ireland Ltd IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 20, 2021	Z-1859-2021	—	terminated	The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Oct 9, 2019	Z-1775-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1777-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1774-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1773-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1776-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1772-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1778-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Aug 3, 2015	Z-2761-2015	—	terminated	Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.